Carpal Tunnel SyndromeNCT00655915
Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release
An observational study of Carpal Tunnel Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will investigate whether symptomatic improvement following carpal tunnel corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel release and therefore serve as a prognostic indicator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome
Who may be able to join
- Patients with a clinical diagnosis of carpal tunnel syndrome
- English speaking patients only
Who cannot join
- Patients less than 18 years old
- Patients who are pregnant by patient report or intending to become pregnant during the study
- Patients unwilling or unable to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse to participate.
- Patients with evidence of thenar atrophy on exam
- Patients with a diagnosis of peripheral neuropathy or other neuropathy.
- Patients with previous ipsilateral carpal tunnel injection or release.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Hand & Upper Extremity Center
Nashville, Tennessee, 37232-8828
About this study
This study will investigate whether symptomatic improvement following carpal tunnel corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel release and therefore serve as a prognostic indicator.
Clinical question: Does response to corticosteroid injection in CTS predict outcomes of surgical treatment?
Read more
Secondary Questions:
- Can we confirm previous retrospectively collected data that a certain percentage of conservatively managed patients with steroid injection will avoid surgery, and that patients who undergo surgery will have better outcomes than those who do not.
- Are there differences between worker's compensation and non-worker's compensation patients with regard to the primary clinical question?
- What are Carpal Tunnel Release outcomes for the subset of patients with negative electrophysiologic studies?
- What are the outcomes of patients who undergo carpal tunnel release vs. those who choose not to undergo carpal tunnel release?
A prospective cohort design study is the appropriate study design in order to measure the association between a predictor (response to injection) and outcome (response to surgery).
Read the detailed description
Carpal Tunnel Syndrome is a painful condition that is caused by compression of the median nerve in the wrist. Symptoms usually are pain, weakness, or numbness in the hand and wrist, radiating up the arm. Corticosteroid injections have been utilized in the conservative management of carpal tunnel syndrome for several decades. They have been shown to be relatively safe with a very low reported complication rate. Recent efforts in the literature have shown they are efficacious for a majority of patients although their effects are usually transient. Several studies have attempted to show a predictive value of corticosteroid injection with regard to who will ultimately benefit from carpal tunnel release. There is a trend towards positive predictability with several retrospective studies showing that patients who have a clinical benefit from steroid injection are more likely to have a successful outcome from carpal tunnel release. Carpal tunnel release remains the definitive treatment option for carpal tunnel syndrome, and a clinical test which could give the practitioner and patient additional information regarding likelihood of successful outcome of surgery would be a valuable prognostic tool.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% LidocaineOther
Patients will receive a carpal tunnel injection of 1 mg of betamethasone and 1 mL of 1% lidocaine will be infiltrated by small gauge (ie. 25- or 27-gauge) needle via attending surgeon preference. These are routinely performed by injecting 1cm proximal to distal wrist crease just ulnar to palmaris longus tendon although multiple techniques have been described. Elicitation of median nerve symptoms during needle placement requires redirecting needle prior to injection to avoid median nerve infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Injection Patients | Those patients who receive corticosteroid injections for carpal tunnel syndrome Receives: Other: Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Study was terminated by principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Jeffry T Watson, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655915
- Sponsor's protocol ID
- 071107
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2008
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT00655915
- Acronym / sponsor ID
- 071107
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated by principal investigator
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether symptomatic improvement following carpal tunnel corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel release and therefore serve as a prognostic indicator.
Clinical question: Does response to corticosteroid injection in CTS predict outcomes of surgical treatment?
Secondary Questions:
- Can we confirm previous retrospectively collected data that a certain percentage of conservatively managed patients with steroid injection will avoid surgery, and that patients who undergo surgery will have better outcomes than those who do not.
- Are there differences between worker's compensation and non-worker's compensation patients with regard to the primary clinical question?
- What are Carpal Tunnel Release outcomes for the subset of patients with negative electrophysiologic studies?
- What are the outcomes of patients who undergo carpal tunnel release vs. those who choose not to undergo carpal tunnel release?
A prospective cohort design study is the appropriate study design in order to measure the association between a predictor (response to injection) and outcome (response to surgery).
Detailed description
Carpal Tunnel Syndrome is a painful condition that is caused by compression of the median nerve in the wrist. Symptoms usually are pain, weakness, or numbness in the hand and wrist, radiating up the arm. Corticosteroid injections have been utilized in the conservative management of carpal tunnel syndrome for several decades. They have been shown to be relatively safe with a very low reported complication rate. Recent efforts in the literature have shown they are efficacious for a majority of patients although their effects are usually transient. Several studies have attempted to show a predictive value of corticosteroid injection with regard to who will ultimately benefit from carpal tunnel release. There is a trend towards positive predictability with several retrospective studies showing that patients who have a clinical benefit from steroid injection are more likely to have a successful outcome from carpal tunnel release. Carpal tunnel release remains the definitive treatment option for carpal tunnel syndrome, and a clinical test which could give the practitioner and patient additional information regarding likelihood of successful outcome of surgery would be a valuable prognostic tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection Patients | – | Other: Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% LidocaineThose patients who receive corticosteroid injections for carpal tunnel syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of carpal tunnel syndrome
- English speaking patients only
Key exclusion criteria (7 listed)
- Patients less than 18 years old
- Patients who are pregnant by patient report or intending to become pregnant during the study
- Patients unwilling or unable to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse to participate.
- Patients with evidence of thenar atrophy on exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% LidocainePatients will receive a carpal tunnel injection of 1 mg of betamethasone and 1 mL of 1% lidocaine will be infiltrated by small gauge (ie. 25- or 27-gauge) needle via attending surgeon preference. These are routinely performed by injecting 1cm proximal to distal wrist crease just ulnar to palmaris longus tendon although multiple techniques have been described. Elicitation of median nerve symptoms during needle placement requires redirecting needle prior to injection to avoid median nerve infiltration. | Other | Injection Patients |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study was terminated by principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffry T Watson, M.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated by principal investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2011.